FDA.reportPublic FDA data

Stronghold PP/PE Isolation Gown (AAMI Level 2)-XL

Primary DI
00850037694716
Brand
Stronghold PP/PE Isolation Gown (AAMI Level 2)-XL
Company
The Stronghold Group LLC
Model
SC200XL
Device description
This gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate materials. Not intended for use in the operating room. This gown is classified as Level 2 per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. Pack of 10.
Published
2022-03-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
OEANon-Surgical Isolation Gown

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEANon-Surgical GownGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850037694716PackageGS110In Commercial Distribution
00850037694679PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850037694716008500376947168500376947160850037694716
00850037694679008500376946798500376946790850037694679

GMDN Terms#

Term, Definition table
TermDefinition
Isolation gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080344373
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850037694648Stronghold PP/PE Isolation Gown (AAMI Level 2)-SSC200S2022-03-19
00850037694655Stronghold PP/PE Isolation Gown (AAMI Level 2)-MSC200M2022-03-19
00850037694662Stronghold PP/PE Isolation Gown (AAMI Level 2)-LSC200L2022-03-19
00850037694679Stronghold PP/PE Isolation Gown (AAMI Level 2)-XLSC200XL2022-03-19
00850037694686Stronghold PP/PE Isolation Gown (AAMI Level 2)-UnisizeSC200U2022-03-19
00850037694730Stronghold SMS Isolation Gown (AAMI Level 2)-SSC210S2022-03-19
00850037694747Stronghold SMS Isolation Gown (AAMI Level 2)-MSC210M2022-03-19
00850037694754Stronghold SMS Isolation Gown (AAMI Level 2)-LSC210L2022-03-19
00850037694761Stronghold SMS Isolation Gown (AAMI Level 2)-XLSC210XL2022-03-19
00850037694778Stronghold SMS Isolation Gown (AAMI Level 2)-UnisizeSC210U2022-03-19
10850037694645Stronghold PP/PE Isolation Gown (AAMI Level 2)-SSC200S2022-03-19
00850037694693Stronghold PP/PE Isolation Gown (AAMI Level 2)-MSC200M2022-03-19
00850037694709Stronghold PP/PE Isolation Gown (AAMI Level 2)-LSC200L2022-03-19
00850037694723Stronghold PP/PE Isolation Gown (AAMI Level 2)-UnisizeSC200U2022-03-19
00850037694785Stronghold SMS Isolation Gown (AAMI Level 2)-SSC210S2022-03-19
00850037694792Stronghold SMS Isolation Gown (AAMI Level 2)-MSC210M2022-03-19
00850037694808Stronghold SMS Isolation Gown (AAMI Level 2)-LSC210L2022-03-19
00850037694815Stronghold SMS Isolation Gown (AAMI Level 2)-XLSC210XL2022-03-19
00850037694822Stronghold SMS Isolation Gown (AAMI Level 2)-UnisizeSC210U2022-03-19
00860007372209Stronghold Group Nitrile Examination Glove, Powder Free-SSHFBSNS0603S2022-03-08

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Primary DI, Brand, Company table
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